A Pharmacokinetics and Safety of Methylphenidate HCl in Healthy Japanese Adult Male Volunteers

An Open-label, Single-Ascending-Dose Study to Investigate the Pharmacokinetics and Safety of CONCERTA in Healthy Japanese Adult Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01202734

Enrollment

Registered

2010-09-16

Start date

2010-09-30

Completion date

2010-11-30

Last updated

2014-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

CONCERTA, Methylphenidate HCl, Pharmacokinetic, Safety, Adult, Men, Male

Brief summary

The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of Methylphenidate HCl in healthy Japanese adult male volunteers.

Detailed description

This is an open-label (name of assigned treatment is known), single-center study of the pharmacokinetics (blood levels) and safety of 3 single doses of methylphenidate HCl administered orally (by mouth) to healthy Japanese adult male volunteers. Methylphenidate HCl is a drug that is currently approved for the treatment of adults with attention-deficit/hyperactivity disorder (ADHD) in regions outside Japan, including the United States where this study will be conducted. Volunteers will participate in the study for a maximum of 42 days. Blood samples will be collected from volunteers during the study to determine the concentration of the methylphenidate HCl in the blood after dosing. Safety will be monitored throughout the study by evaluating adverse events reported, changes in clinical laboratory test results, vital signs measurements, physical examination results, and other protocol-specified safety assessments. All volunteers will receive a single oral dose of methylphenidate HCl with 240 mL (1 cup) of noncarbonated water after at least a 10-hour fast (without eating food) during 3 treatment periods as follows: Period 1, one 36-mg tablet; Period 2, three 18-mg tablets; and Period 3, two 36-mg tablets. Treatment periods will be separated by 3 to 7 days. Volunteers will continue fasting until at least 4 hours after dosing.

Interventions

DRUGMethylphenidate HCl

Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive * Body weight of not less than 50 kg * Supine (lying down) blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic

Exclusion criteria

* History of or current medical illness judged by the investigator to be clinically significant * Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of study drug * History of drug or alcohol abuse within the past 5 years * History of smoking or use of nicotine containing substances within the previous 2 months

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of total methylphenidate HCl and its major metabolite, a-phenyl-piperidine-acetic acid (PPAA)	At protocol-specified times on Day 1 through Day 3 in Treatment Periods 1, 2, and 3

Secondary

Measure	Time frame
The number and type of treatment-emergent adverse events	Day 1 of Period 1 through Day 3 of Period 3 (approximately 23 days)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026